A framework to guide dose & regimen strategy for clinical drug development

Optimizing new drug therapies remains a challenge for clinical development, despite the use of ever more sophisticated quantitative methodologies. Although conceptually simple, the idea of finding the right treatment at the right dose for the right patient to ensure an appropriate balance of risks a...

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Autores principales: Sander, Oliver, Magnusson, Baldur, Ludwig, Inga, Jullion, Astrid, Meille, Christophe, Lorand, Daniel, Bornkamp, Björn, Hinder, Markus, Kovacs, Steven J., Looby, Michael
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Perspectives
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8592517/
https://www.ncbi.nlm.nih.gov/pubmed/34562310
http://dx.doi.org/10.1002/psp4.12701
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author Sander, Oliver
Magnusson, Baldur
Ludwig, Inga
Jullion, Astrid
Meille, Christophe
Lorand, Daniel
Bornkamp, Björn
Hinder, Markus
Kovacs, Steven J.
Looby, Michael
author_facet Sander, Oliver
Magnusson, Baldur
Ludwig, Inga
Jullion, Astrid
Meille, Christophe
Lorand, Daniel
Bornkamp, Björn
Hinder, Markus
Kovacs, Steven J.
Looby, Michael
author_sort Sander, Oliver
collection PubMed
description Optimizing new drug therapies remains a challenge for clinical development, despite the use of ever more sophisticated quantitative methodologies. Although conceptually simple, the idea of finding the right treatment at the right dose for the right patient to ensure an appropriate balance of risks and benefits is challenging and requires a multidisciplinary approach. In this paper, we present a framework developed as a tool for organizing knowledge and facilitating collaboration in development teams.
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spelling pubmed-85925172021-11-22 A framework to guide dose & regimen strategy for clinical drug development Sander, Oliver Magnusson, Baldur Ludwig, Inga Jullion, Astrid Meille, Christophe Lorand, Daniel Bornkamp, Björn Hinder, Markus Kovacs, Steven J. Looby, Michael CPT Pharmacometrics Syst Pharmacol Perspectives Optimizing new drug therapies remains a challenge for clinical development, despite the use of ever more sophisticated quantitative methodologies. Although conceptually simple, the idea of finding the right treatment at the right dose for the right patient to ensure an appropriate balance of risks and benefits is challenging and requires a multidisciplinary approach. In this paper, we present a framework developed as a tool for organizing knowledge and facilitating collaboration in development teams. John Wiley and Sons Inc. 2021-09-25 2021-11 /pmc/articles/PMC8592517/ /pubmed/34562310 http://dx.doi.org/10.1002/psp4.12701 Text en © 2021 The Authors. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Perspectives
Sander, Oliver
Magnusson, Baldur
Ludwig, Inga
Jullion, Astrid
Meille, Christophe
Lorand, Daniel
Bornkamp, Björn
Hinder, Markus
Kovacs, Steven J.
Looby, Michael
A framework to guide dose & regimen strategy for clinical drug development
title A framework to guide dose & regimen strategy for clinical drug development
title_full A framework to guide dose & regimen strategy for clinical drug development
title_fullStr A framework to guide dose & regimen strategy for clinical drug development
title_full_unstemmed A framework to guide dose & regimen strategy for clinical drug development
title_short A framework to guide dose & regimen strategy for clinical drug development
title_sort framework to guide dose & regimen strategy for clinical drug development
topic Perspectives
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8592517/
https://www.ncbi.nlm.nih.gov/pubmed/34562310
http://dx.doi.org/10.1002/psp4.12701
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